The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery
Eligibility criteria
Qualifiers
Age > 18 years
Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team
Implanted cardioverter defibrillator (ICD) any time in past with remote monitoring or planned to undergo ICD (or ICM as an alternative, if an ICD cannot be implanted for a clinical reason) implant within the index hospitalization for LVAD implant
History of treated or monitored sustained (i.e., >30 seconds in duration ) VT or VF episode within the past 5 years.
Disqualifiers
Past successful VTA ablation without recurrent VTA prior to LVAD implant (Patients who continue to experience VTA post ablation and pre LVAD implant qualify to be enrolled)
Participation in other clinical trials (observational registries are allowed with approval)
Unable or unwilling to provide informed consent
Trial design
Treatments tested in this trial
- Intra-Op Prophylactic VT ablation
- Conventional Management
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
19Arizona
Banner University Medical Center85006, Phoenix United States
California
UCLA Cardiac Arrthmia Center90095, Los Angeles United States
University of California San Francisco94143, San Francisco United States
District of Columbia
Medstar Washington Hospital Center20010, Washington D.C. United States
Sponsors and collaborators
University of Rochester
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov